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510(k) Data Aggregation

    K Number
    K123699
    Device Name
    FAHL TRACHEOSTOMY TUBES (MULTIPLE)
    Manufacturer
    ANDREAS FAHL MEDIZINTECHNIK-VERTRIEB GMBH
    Date Cleared
    2013-08-12

    (252 days)

    Product Code
    JOH, BTO, BTR
    Regulation Number
    868.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANDREAS FAHL MEDIZINTECHNIK-VERTRIEB GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fahl Tracheostomy Tubes are intended to provide tracheal access for airway management of tracheostomized patients.
    Device Description
    The Fahl Tracheostomy Tubes (Duravent, Duracuff, Laryngotec, Duratwix, Silvervent, Spiraflex, and Tracheotec) are available cuffed or uncuffed. They can be obtained sieved or unsieved, with or without speaking valve, cuffed or uncuffed, with or without inner cannulas. The accessories comprise different Humid Moist Exchangers (HME), decannulation plugs, neck holders, and stoma buttons. Fahl offers the tubes in varying sizes and length so that the physician can select a tracheostomy tube, which best fits the individual needs of the patient. All Fahl Tracheostomy Tubes are for adults only and available on prescription.
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